NCT06538766

Brief Summary

The goal of this clinical trial is to investigate the effects of strength training with different focus of attention strategies on plantar flexor force and how this affects gait in apparently healthy older adults. The main questions it aims to answer are:

  • Is there an acute effect of focus of attention on non-linear force variability and the subjacent neurophysiological mechanisms in apparently healthy young and older adults?
  • Is there a training effect of focus of attention on non-linear force variability and does it transfer to non-linear gait variability as well as the respective subjacent neurophysiological mechanisms in apparently healthy older adults? Researchers will compare two different external focus strategies with an internal focus to see if non-linear variability increases and subjacent neurophysiological mechanisms are more automized with an external focus of attention compared to an internal focus. In the acute study young adults are assessed as the differences between focus conditions are thought to be in the same direction as for older adults but attenuated. Participants will carry out training and strength assessments of the calf muscles and walking on a treadmill.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

July 26, 2024

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change from Baseline in Non-linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up

    The non-linear variability of the temporal structure of the force signal of a 50 seconds isometric task at 50% of the maximum voluntary isometric contraction is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular force output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable force output.

    Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

  • Change from Baseline in Non-linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up

    The non-linear variability of the temporal structure of the gait signal from a 12 minutes gait trial is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular gait output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable gait output.

    Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

  • Change from Baseline in Cortico-Spinal Excitability after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal excitability single-pulse TMS is applied. For cortico-spinal excitability the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the EMG maximum voluntary contraction.

    Baseline, Week2, Week4 and Follow-Up (Week6)

  • Change from Baseline in Cortico-Spinal Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal inhibition single-pulse TMS is applied. For cortico-spinal inhibition the mean of electromyographic silent periods from 10 stimulations is calculated. The values are presented in ms.

    Baseline, Week2, Week4 and Follow-Up (Week6)

  • Change from Baseline in Intra-Cortical Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical inhibition paired-pulse TMS is applied. For intra-cortical inhibition the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.

    Baseline, Week2, Week4 and Follow-Up (Week6)

  • Change from Baseline in Intra-Cortical Facilitation after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical facilitation paired-pulse TMS is applied. For intra-cortical facilitation the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.

    Baseline, Week2, Week4 and Follow-Up (Week6)

Secondary Outcomes (5)

  • Change from Baseline in Antagonist Co-Contraction Index after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Baseline, Week2, Week4 and Follow-Up (Week6)

  • Change from Baseline in Linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up

    Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

  • Change from Baseline in Linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up

    Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

  • Change from Baseline of Hip, Knee, Ankle Range of Motion during Gait after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Baseline, Week2, Week4 and Follow-Up (Week6)

  • Change from Baseline of Minimum Toe Clearance during Gait after after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

    Baseline, Week2, Week4 and Follow-Up (Week6)

Study Arms (3)

Internal Focus Condition

ACTIVE COMPARATOR

In the internal focus condition the participant is instructed to realize seated calf raises by focusing on contracting the plantar-flexors. In clinical applications the internal focus is the most commonly used instruction. It is not possible to have a neutral focus condition, as participants always have to receive instructions and will always be focusing on something. Therefore, the internal focus condition is used as an active comparator.

Other: Strength training with an internal focus of attention

Proprioceptive External Focus Condition

EXPERIMENTAL

In the proprioceptive external focus condition the participant is instructed to realize seated calf raises by focusing on lifting the machine's bar.

Other: Strength training with a proprioceptive external focus of attention

Visual External Focus Condition

EXPERIMENTAL

In the visual external focus condition the participant is instructed to realize seated calf raises by focusing on a line representing the displacement of the bar projected on a screen.

Other: Strength training with a visual external focus of attention

Interventions

A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific internal focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.

Internal Focus Condition

A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific proprioceptive external focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.

Proprioceptive External Focus Condition

A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific visual external focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.

Visual External Focus Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Signed informed consent

You may not qualify if:

  • Severe cardiovascular or pulmonary disease
  • Oncological disease
  • Lower limb disabilities
  • Neurological disorders
  • Inability to walk unassisted for 12 continuous minutes
  • Cognitive impairment
  • Falls in the prior 12 months
  • Orthopedic concerns, which might limit force production
  • Metal implants
  • Medicine that can trigger side effects with TMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egas Moniz School of Health & Science

Monte de Caparica, Almada, 2829 - 511, Portugal

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 6, 2024

Study Start

April 1, 2024

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations